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Advance reports: PARTNER trial - three-year data

Peter Sayer

GM, 2013

PARTNER trial: three-year dataThe three-year results of a pivotal clinical study of severe aortic stenosis patients at high-risk for surgery were recently announced at the American College of Cardiology’s (ACC) 62nd Annual Scientific Session in San Francisco, USA. The results continue to demonstrate comparable outcomes between treatment with the Edwards SAPIEN transcatheter heart valve and open-heart surgery. At three years, all-cause mortality for patients treated with the Edwards SAPIEN transcatheter aortic valve implantation (TAVI) delivered via the femoral artery or a small incision between the ribs was statistically equivalent to that of patients who had received open-heart surgical aortic valve replacement (AVR). Symptom improvement and valve performance was similar in both groups and was maintained through the three years of patient follow-up. The incidence of stroke between TAVI and surgery patients was also comparable. The PARTNER Trial is the first randomised, controlled trial of a transcatheter aortic valve in the US. The high-risk surgery cohort (Cohort A) of the trial enrolled between May 2007 and September 2009 and studied 699 patients with severe, symptomatic aortic stenosis deemed at high risk for traditional open-heart surgery. Patients were evaluated by a multidisciplinary heart team and randomised to receive either traditional open-heart surgery or the Edwards SAPIEN valve with transfemoral or transapical delivery. The Food and Drug Administration (FDA) approved the SAPIEN valve in November 2011 for the treatment of inoperable patients, and expanded the indication to high-risk surgical patients in October 2012. Larry L. Wood, Edwards’ corporate vice president, transcatheter heart valves, said: “These three-year data from The PARTNER Trial strengthen the evidence that the SAPIEN valve is a safe and less-invasive alternative for those patients who need valve replacement, but are at high surgical risk. The availability of the SAPIEN valve encourages the many untreated patients to work with a heart team to determine whether transcatheter valve replacement or surgery is the right option for them.” No benefit found from blood pressure drug in treatment of recently hospitalised heart failure patients Despite high hopes that a blood pressure-lowering medication called aliskiren would help people following hospitalisation for heart failure, no beneficial effects were found, according to research presented recently at the ACC. Heart failure is the leading cause of hospitalisation for people over age 65 years, costing billions of dollars annually, and researchers are always on the lookout for more effective treatments. The Aliskiren Trial on Acute Heart Failure Outcomes (ASTRONAUT) is an international, double-blind study that enrolled stable patients hospitalised for heart failure and followed them after discharge. Patients were randomised to receive either aliskiren, starting at 150mg and increasing to 300mg, or placebo, in addition to other standard heart failure therapies. After six months, patients in both groups had a similar likelihood of cardiovascular death or re-hospitalisation for heart failure. However, patients in the aliskiren group did show a statistically significant and sustained drop in one of the study’s secondary endpoints, blood levels of N-terminal proB-type natriuretic peptide (NT-proBNP)—a hormone that increases as heart failure progresses. Mihai Gheorghiade, Professor at Northwestern University’s Feinberg School of Medicine and lead author of the ASTRONAUT study, said: “In the majority of cases, patients’ natriuretic peptide levels correlate with their stage of heart failure and can help physicians plan treatment. It was surprising to see that our study drug did positively affect patients’ levels of this peptide, but this positive effect did not translate into reduced mortality or hospitalisations as we would have expected.”

Chest pain reduced in diabetes patientsA commonly used anti-anginal drug reduces chest pain in patients with type 2 diabetes and appears to have a more pronounced effect in those with poorer glucose control, according to research presented at the ACC. Ranolazine is approved for the treatment of chronic angina, or chest pain, both as first line therapy and as an add-on when symptoms are not relieved with other anti-anginal drugs, including beta-blockers, calcium channel blockers and nitrates. However, this randomised, double-blind, placebo-controlled trial is the first to evaluate the drug in patients with diabetes, coronary artery disease and angina. People with diabetes are at increased risk for coronary artery disease. Patients with diabetes and coronary artery disease also tend to have a higher burden of chest pain or angina than those without diabetes. The Type 2 Diabetes Evaluation of Ranolazine in Subjects with Chronic Stable Angina (TERISA) trial included 927 patients, randomised to receive either 1000mg ranolazine twice daily or matching placebo for eight weeks. To qualify for the study, patients had to have type 2 diabetes, established coronary artery disease and stable angina with at least one angina episode per week. Patients were already taking one or two other anti-anginal drugs. The primary endpoint was self-reported angina frequency between weeks two and eight. Weekly episodes of chest pain were lower in the ranolazine arm at 3.8 episodes per week compared to 4.3 episodes per week with the placebo. A key secondary endpoint was how often people used sublingual nitroglycerin during the same timeframe. This was also lower in the ranolazine arm compared with placebo, 1.7 versus 2.1 doses per week. Mikhail Kosiborod, Associate Professor of Medicine at the University of Missouri, Kansas City, Cardiologist at St Luke’s Mid America Heart Institute and the study’s lead author, said: “Angina is associated with worse quality of life, increased risk of hospitalization and higher health care costs and appears to be more prevalent in patients with diabetes. While ranolazine was shown to be effective in reducing angina in prior studies, this is the first time it has been prospectively evaluated in patients with diabetes—a high-risk and therapeutically challenging group.”

Millions of older people with diabetes denied proper care Older people with diabetes are needlessly developing devastating complications because they are being denied proper care and aggressive treatment according to Professor Alan Sinclair, Director at Institute of Diabetes for Older People (IDOP). Speaking recently he said it was wrong that younger people were routinely being given treatments that were denied to those who are older. Over half (54%) of Britain’s 3.8 million people with diabetes are 60 years or over and people in this age group are most at risk of complications of the disease, and it is estimated that by 2030 the number of people with diabetes in the UK over 60 will increase to 60%. Yet Professor Sinclair warns that, while younger people with diabetes are routinely offered “aggressive treatments” to prevent these complications, older people often get overlooked. “It’s a tragedy that so many elderly people suffer these complications when they could be so easily prevented if they were given the care and treatment that they need,” said Professor Sinclair. Serious complications of diabetes include diabetic retinopathy—the leading cause of blindness in the UK—nerve damage, kidney disease, heart disease and even the need for the amputation of limbs. In the last few years there has been a huge increase in avoidable complications in retinopathy (118%), stroke (87%), kidney failure (56%) and cardiac failure (43%). It is estimated that of more than 100 amputations carried out each week from diabetes complications, up to 80% are preventable. Currently older patients with diabetes complications occupy 15% of all hospital beds and Professor Sinclair predicts that by 2030 this figure will rocket to one in four hospital beds, costing taxpayers £465.25 million per year (due to 1.34 million diabetes bed days). “If nothing is done now to improve the care of older people with type 2 diabetes, the effect on patients and the NHS could be catastrophic – the impending diabetes time bomb could potentially bankrupt the already stretched service,” he added. To address these issues and ensure older patients with type 2 diabetes receive better care, IDOP launched the “European Diabetes Working Party for Older People Clinical Guidelines for Type 2 Diabetes Mellitus (EDWPOP)”. This is a set of user-friendly recommendations for doctors, nurses and care home managers who work with or care for older people with diabetes. The EDWPOP guidelines have been developed to address care gaps highlighted in a Position Statement developed by the International Association of Gerontology and Geriatrics (IAGG), the European Diabetes Working Party for Older People (EDWPOP) and the International Task Force of Experts. The Position Statement identified a need for specific guidelines as previous guidelines did not focus on the needs of older people. The collaborative expert group explored the key issues that affect diabetes in older people using a rigorous consensus approach, along with an evidence-based review of literature. Gaps in care identified include: • The use of exercise-, nutrition-, and glucose-lowering therapies in the effective management of type 2 diabetes in older people • Practical community-based interventions to reduce hospitalisation • Methods to decrease hypoglycaemia rates in various clinical settings • Health economic evaluations of metabolic treatment • Interventions to delay/prevent diabetes-related complications that are important in older age, such as cognitive impairment and functional dependence • Development of technical devices that help to maintain autonomy and safety for older people with diabetes. The EDWPOP guidelines provide an evidence-based and detailed summary of what healthcare professionals across Europe should be doing now to give patients the best diabetes care possible. They include: • An evidence-based review of treatment for older people with diabetes, intended as a resource for clinical decision-making • A user-friendly set of recommendations for primary care, the community and secondary care settings • Guidance in 18 areas of clinical interest, such as screening and diagnosis, prevention, secondary complications, hypoglycaemia, cognitive impairment, falls and immobility.

Diabetes targets not being metOnly one in five people with diabetes in England and Wales is reaching the targets for keeping their condition under control, according to a new analysis by Diabetes UK. The analysis, based on data from the National Diabetes Audit, shows that 19.9% of people with diabetes (all types) in England meet the recommended targets for blood glucose, blood pressure and cholesterol. In Wales, this figure is just 18.5%. For type 1 diabetes the situation is even worse, with just 11.4% of people in England with this type of the condition meeting the treatment target. This is one of the main reasons for the high rates of diabetes-related complications such as kidney failure and stroke, and goes a long way towards explaining why 24,000 people with diabetes die early every year in England and Wales. A big increase in the number of people with diabetes who get the nine annual checks recommended by NICE and are then given support to meet their treatment targets. At the moment just 54% of people with diabetes in England are receiving the checks. There are some areas where fewer than 20% of people with the condition are getting the checks. With the number of people with diabetes increasing rapidly, the UK faces a public health disaster unless the Government makes improving diabetes healthcare an urgent priority. As well as diabetes-related complications having a devastating personal effect, they are also very expensive to treat. The NHS spends about £10 billion a year on diabetes—10% of its entire budget—and about 80% of this goes on treating complications that could often have been prevented. Barbara Young, Chief Executive of Diabetes UK, said: “Given that diabetes is serious, and can lead to early death if people with diabetes are not supported to manage their condition, it is extremely worrying that so few people have it under control. There are now three million people diagnosed with diabetes, and this number is rising quickly. The fact that so many of them do not have good control over their diabetes means that unless something changes we face a public health disaster. Whether these people have high blood glucose levels, blood pressure or cholesterol, they are at increased risk of diabetes-related complications such as heart disease, amputation, and stroke.”